Cleared Traditional

K980895 - ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR

K980895 · California Institute of Tissue Eng. & Instrumenti · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
242d
Days
-
Risk

K980895 is an FDA 510(k) clearance for the ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by California Institute of Tissue Eng. & Instrumenti (Visalia, US). The FDA issued a Cleared decision on November 6, 1998 after a review of 242 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all California Institute of Tissue Eng. & Instrumenti devices

FDA 510(k) Submission Details - K980895

510(k) Number K980895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1998
Decision Date November 06, 1998
Days to Decision 242 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 115d · This submission: 242d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 133
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K980895.
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MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4
K982841 · Misonix, Inc. · Sep 1998